Posted by Michael Wonder on 13 Aug 2018
Gottlieb: FDA will streamline drug safety evaluations
10 August 2018 - The FDA will soon standardise the way it handles data on the safety and effectiveness of drugs in an effort to reduce inconsistencies in the drug review process, agency Commissioner Scott Gottlieb said Friday.
“Rather than just looking at drug safety parameters in terms of the tables that are submitted to us, we’re going to actually take the raw data and evaluate it into custom tables, that the agency’s going to develop, that are going to be standardised across all our review divisions,” Gottlieb said.
